Medtronic

A16707-098, A16707-099, A16707-100, A16707-101, A16707-102, A16707-103, A16707-104, A16707-105, A16707-106, A16707-107, A16707-108, A16707-109, A16707-110, A16707-111, A16707-112, A16707-113, A16707-114, A16707-115, A16707-116, A16707-117, A16707-118, A16707-119, A16707-120, A16707-121, A16707-122, A16707-123, A16707-124, A16707-125, A16707-142, and A16707-147

Orthopedic Devices

2

Yes

US Distribution in the states of: MO, FL, MN, OH, MI, TX, and NJ.

Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 || Orthopaedic - filler, bone void

Model No. BI-700-00027 and BI-700-00028 Serial number range: 00102 through 00753 and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769

Radiology Devices

2

No

USA (nationwide) Distribution

Medtronic O-arm Imaging System Mobile X-ray system. || Model No. BI-700-00027 and BI-700-00028 || The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.

Model 78618, Lot numbers: 2011041199, 2011062306, 2011100971, 2011102092,  2011120307, 2012051764, 2012061644, 2012080274, 2012110107, 2012120373,  2013010071, 2013050197, 2013081170, 2013102358, 201203C853.   Model 78620, Lot numbers: 2011030255, 2011040939, 2011041341, 2011101160 2011111043, 2012011041, 2012020540, 2012070617, 2012110017, 2012111257,  2013031297, 2013050408, 2013060024, 2013060816, 2013070896, 2013090420,  2013091570, 2013101359.   Model 78718, Lot numbers: 2011020219, 2011051461, 2011051501, 2011060279,  2011081265, 2011091551, 2011100022, 2011111305, 2012011048, 2012032171,  2012040645, 2012070832, 2012071313, 2013031493, 2013041737, 2013051367,  2013060409, 2013091960, 2013102157, 2013110588, 201110C116, 201203C855.   Model 78720, Lot numbers: 2011010067, 2011021825, 2011062606, 2011062607,  2011070536, 2011071117, 2011080605, 2011081029, 2011081501, 2011082463,  2011090046, 2011090047, 2011100092, 2012011142, 2012011424, 2012051863,  2012060210, 2012061344, 2012061868, 2012120133, 2012120781, 2012120941,  2012121072, 2013030331, 2013030943, 2013080633, 2013081206, 2013110894,  2013120553.

Cardiovascular Devices

2

No

Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.

Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. || The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. || The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). || These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

Model 78622, Lot numbers: 2011031714, 2011040345, 2011050373, 2011060471,  2011060641, 2011060642, 2011070099, 2011072408, 2011081502, 2011102965,  2011111215, 2011120575, 2012011143, 2012011425, 2012020052, 2012040536,  2012051387, 2012090216, 2012101333 ,2013010957, 2013011791, 2013020303,  2013030729, 2013040209, 2013040282, 2013040710, 2013041272, 2013051447,  2013060736, 2013071836, 2013072009, 201105C105, 201203C854.   Model 78722, Lot numbers: 2011031588, 2011031885, 2011051006, 2011051226,  2011061585, 2011071672, 2011082216, 2011091825 , 2011101670, 2011102093,  2011110717, 2011120059, 2012060478, 2012061056, 2012061057, 2012061725,  2012070570, 2012090657, 2013011121, 2013021260, 2013030685, 2013040494,  2013040595, 2013070162, 2013070483, 2013081289, 2013081603, 201108C227.

Cardiovascular Devices

2

No

Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.

Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. || The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body. The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation. The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap. The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. || These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

Model 78624, Lot numbers: 2011010432, 2011010514, 2011010515, 2011011141,  2011011543, 2011021907, 2011040344, 2011040946, 2011060613, 2011060865,  2011070535, 2011071749, 2011081635, 2011110330, 2011120304, 2011120305,  2011121133, 2012060424, 2012060431, 2012070886, 2012080324, 2012081353,  2012081928, 2012090013, 2012120521, 2012121021, 2012121414, 2013031142,  2013050555, 2013050805, 2013051225, 2013051640, 2013060249, 2013090499,  2013090570, 2013091332, 2013091924, 201106C140, 201203C844, 201310C579.   Model 78724, Lot numbers: 2011032145, 2011050718, 2011060852, 2011092067,  2011102225, 2012032345, 2012071614, 2012081704, 2012081973, 2013031364,  2013051818, 2013060581, 2013070831, 2013080858, 2013100654, 2013110548,  2014010275, 201108C228, 201203C842.

Cardiovascular Devices

2

No

Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.

Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. || The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body. The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation. The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap. The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. || These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.